Novavax Initiates Phase 2 Clinical Trial of NanoFlu™ in Older Adults
September 25 2018 - 7:00AM
Novavax Initiates Phase 2 Clinical Trial of NanoFlu™ in Older
Adults
Novavax, Inc. (NASDAQ: NVAX) today announced the initiation of a
Phase 2 dose and formulation confirmation clinical trial in older
adults of NanoFlu, its nanoparticle seasonal influenza vaccine
candidate.
“Initiating this Phase 2 clinical trial of
NanoFlu is an important milestone for Novavax,” said Stanley C.
Erck, President and Chief Executive Officer of Novavax. “With
top-line results expected in the first quarter of 2019, we plan to
discuss these data with the FDA at an ‘End of Phase 2’ meeting and
to agree on the appropriate Phase 3 clinical trial design to
support licensure via accelerated approval. We continue to believe
NanoFlu is a differentiated flu vaccine capable of better
addressing a global public health problem, and can thereby capture
a significant share of the multi-billion-dollar seasonal influenza
vaccine market.”
This randomized, observer-blinded,
active-controlled trial will assess the safety and tolerability of
different doses and formulations of NanoFlu, both adjuvanted with
its proprietary Matrix-M™ adjuvant and unadjuvanted, as compared to
two U.S.-licensed comparators. The trial will enroll approximately
1,375 healthy older adults across clinical sites in the U.S. and is
designed to select a dose/formulation of NanoFlu that Novavax will
bring forward into its future pivotal Phase 3 immunogenicity
clinical trial.
“The dual problems of antigenic drift and
antigenic changes resulting from egg-based vaccine production have,
in recent years, resulted in generally poor influenza vaccine
effectiveness with potentially severe medical consequences,
particularly in older adults. A substantially improved seasonal
influenza vaccine is a widely recognized, high-priority unmet
medical need,” said Gregory Glenn, M.D., President of Research and
Development of Novavax. “We look forward to evaluating NanoFlu in
this trial, and subsequently moving into a pivotal Phase 3 clinical
trial in the second half of 2019 with the goal of introducing a
more effective flu vaccine option.”
More information about the newly initiated trial
can be found at www.clinicaltrials.gov.
Previously Reported Phase 1/2 Clinical
Trial Results with NanoFlu
In February 2018, Novavax reported positive
top-line results from its Phase 1/2 clinical trial in older adults
of a NanoFlu trivalent formulation. As compared to Fluzone HD,
NanoFlu demonstrated an acceptable safety profile and short-term
reactogenicity. With regard to immunogenicity, NanoFlu induced:
- Hemagglutination inhibition (HAI) immune responses that were
28% to 64% greater against the homologous and four generations of
drifted wild-type A(H3N2) influenza strains;
- Higher HAI responses against the homologous A(H1N1) strain and
comparable responses against the homologous B/Brisbane strain;
and
- Strong neutralizing antibody responses that correlate with HAI
results.
About Influenza
Influenza is a world-wide infectious disease
that causes illness in humans with symptoms ranging from mild to
life-threatening or even death. Serious illness occurs not only in
susceptible populations such as infants, young children and older
adults, but also in the general population largely because of
infection by continuously evolving strains of influenza which can
evade the existing protective antibodies in humans. An estimated
one million deaths globally each year are attributed to influenza.1
Current estimates for seasonal influenza vaccine growth in the top
seven markets (U.S., Japan, France, Germany, Italy, Spain and UK),
show a potential increase from approximately $3.2 billion in 2015
to $5.3 billion by 2025.2
1 Resolution of the World Health Assembly (2003) WHA56.19.28
2 Influenza Vaccines Forecasts. Datamonitor (2013)
About NanoFlu™ and
Matrix-M™
NanoFlu is a recombinant hemagglutinin (HA)
protein nanoparticle influenza vaccine produced by Novavax in its
SF9 insect cell baculovirus system. NanoFlu uses HA amino acid
protein sequences that are the same as the recommended wild-type
circulating virus HA sequences. NanoFlu contains Novavax’ patented
saponin-based Matrix-M adjuvant, which has demonstrated a potent
and well-tolerated effect by stimulating the entry of
antigen-presenting cells into the injection site and enhancing
antigen presentation in local lymph nodes.
About Accelerated Approval
Accelerated approval may be granted for certain
biological products that have been studied for their safety and
effectiveness in treating serious or life-threatening illnesses and
that provide meaningful therapeutic benefit over existing
treatments. Such an approval will be based on adequate and
well-controlled clinical trials establishing that the biological
product has an effect on a surrogate endpoint that is reasonably
likely to predict clinical benefit. For seasonal influenza
vaccines, the hemagglutination inhibition (HAI) antibody response
may be an acceptable surrogate marker of activity that is
reasonably likely to predict clinical benefit. To be considered for
accelerated approval, a biologics license application for a new
seasonal influenza vaccine should include results from one or more
well-controlled studies designed to meet immunogenicity endpoints
and a commitment to conduct confirmatory post-marketing studies of
clinical effectiveness in preventing influenza.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a late-stage
biotechnology company that drives improved health globally through
the discovery and development of innovative vaccines to prevent
serious respiratory diseases. ResVax, its RSV vaccine for infants
via maternal immunization, is the only vaccine in a Phase 3
clinical program and is poised to help prevent the second leading
cause of death in children under one year of age worldwide. Novavax
is also advancing NanoFlu, its quadrivalent influenza nanoparticle
vaccine, to address key factors that can lead to the poor
effectiveness of currently approved flu vaccines. Novavax is a
leading innovator of recombinant vaccines; its proprietary
recombinant technology platform combines the power and speed of
genetic engineering to efficiently produce a new class of highly
immunogenic nanoparticles addressing urgent global health
needs.
For more information, visit www.novavax.com and
connect with us on Twitter and LinkedIn.
Forward-Looking Statements
Statements herein relating to the future of
Novavax and the ongoing development of its vaccine and adjuvant
products are forward-looking statements. Novavax cautions that
these forward-looking statements are subject to numerous risks and
uncertainties, which could cause actual results to differ
materially from those expressed or implied by such statements.
These risks and uncertainties include those identified under the
heading “Risk Factors” in the Novavax Annual Report on Form 10-K
for the year ended December 31, 2017 and the Quarterly Report on
Form 10-Q for the period ended June 30, 2018 as filed with the
Securities and Exchange Commission (SEC). We caution investors not
to place considerable reliance on the forward-looking statements
contained in this press release. You are encouraged to read our
filings with the SEC, available at sec.gov, for a discussion of
these and other risks and uncertainties. The forward-looking
statements in this press release speak only as of the date of this
document, and we undertake no obligation to update or revise any of
the statements. Our business is subject to substantial risks and
uncertainties, including those referenced above. Investors,
potential investors, and others should give careful consideration
to these risks and uncertainties.
Contacts:
InvestorsNovavax, Inc.Erika TrahanSenior Manager, Investor &
Public Relationsir@novavax.com240-268-2000
Westwicke PartnersJohn
Woolfordjohn.woolford@westwicke.com443-213-0506
MediaSam BrownMike Beyermikebeyer@sambrown.com312-961-2502
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